Chelsea Therapeutics International, Ltd. announced that the Cardiovascular and Renal Drug Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the New Drug Application (NDA) filed for Northera in Jul 2013. The meeting is scheduled to take place on Jan 14, 2014.
Chelsea Therapeutics is looking to get Northera approved for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure).
The FDA’s decision on the approval of Northera is expected by Feb 14, 2014. We note that Northera enjoys both orphan drug designation and fast track designation in the U.S.
After the NDA was resubmitted in Jul 2013, the FDA had informed Chelsea Therapeutics of deficiencies in the NDA regarding the formatting of certain submitted electronic datasets and statistical programs describing the methods used to generate tables and listings.
In Aug 2013, Chelsea Therapeutics had submitted additional information to the FDA to resolve certain technical deficiencies in the NDA. Following the submission of the additional information, the U.S. regulatory body acknowledged it as a complete response to the complete response letter (CRL) issued by it in Mar 2012. The CRL was issued in response to the NDA filed by the company in Sep 2011.
Chelsea Therapeutics currently carries a Zacks Rank #2 (Buy). The successful development and subsequent commercialization of Northera will be a major milestone for Chelsea Therapeutics, which currently does not have any marketed product in its portfolio. Currently, companies like Roche (RHHBY - Analyst Report), Isis Pharmaceuticals, Inc. (ISIS - Analyst Report) and Actelion Ltd. (ALIOF) look more attractive with a Zacks Rank #1 (Strong Buy).